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U.S. Department of Health and Human Services

Class 2 Device Recall GEM 2753 Microvascular Anastomotic Coupler

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 Class 2 Device Recall GEM 2753 Microvascular Anastomotic Couplersee related information
Date Initiated by FirmMay 14, 2008
Date PostedAugust 02, 2008
Recall Status1 Terminated 3 on April 09, 2010
Recall NumberZ-2138-2008
Recall Event ID 48974
510(K)NumberK040163 
Product Classification Microvascular Anastomotic Device - Product Code MVR
ProductGEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation Sterilized This is a microsurgical coupler used in the anastomosis of veins and arteries normally encountered in microsurgical vascular reconstructive procedures.
Code Information Lot numbers: 1808, 1894, 1907, 1923, 1953, 1954, 7139, 7211, 7354, 8998, 8999, 11591, 12364, 15244, 15280, 15281, 18824, 18912, 19294, 19413, 19954, 20263, 20689, 21345, 21515, 21560, 21977, 22556, and 23047
Recalling Firm/
Manufacturer		 Synovis Micro Companies Alliance Inc
439 Industrial Ln
Birmingham AL 35211-4464
For Additional Information ContactMary L. Frick
615-796-7317
Manufacturer Reason
for Recall		Coupler rings may slip out of the delivery toolcaused by jaws larger than specification.
FDA Determined
Cause 2		Device Design
ActionUrgent Recall Notification was sent via Fed Ex on May 15, 2008 to 432 hospitals. The letters were addressed to the attention of the Risk Manager. The recall notification instructed the hospital to immediately discontinue use, examine their inventory and, if found, to remove the product and quarantine it for return. A second notification was sent on July 21, 2008 to non-responding consignees.
Quantity in Commerce3,812 units
DistributionWorldwide Distribution --- including USA and countries of Canada, Japan, UAE, Korea, South Africa, Australia, Taiwan, Norway, Netherlands, Sweden, Greece, Norway, Turkey, Portugal, Taiwan, Denmark, Italy, Germany, Japan, Spain, Austria, and Great Britain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MVR
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